about 2 months ago
Clinical Data Manager
An exciting medical devices company in the Greater Boston Area that are developing and a novel technology used in multiple organ surgery are looking for an experienced and motivated Clinical Data Manager to oversee the entire life cycle of one of their ongoing clinical trials!
Essential Tasks and Duties Include:
- Be an active member of the entire life cycle of clinical trial data management.
- Communicate and collaborate with Clinical Trial Managers, CRAs, internal/external stakeholders, senior leadership and the rest of the team in ensuring the maximisation of the clinical data to improve patients’ lives.
- Guide, interact, and collaborate with project managers and team members to support the set-up, maintenance, and close out of the data management aspects of global clinical trials to ensure high data quality
- Participate in the design of Electronic Case Report Forms (eCRF) to ensure consistency with study protocol, clinical requirements, and accurate and efficient data collection
- Create, review and maintain project data management documents according to SOP and/or Work Instructions, including eCRF
- Completion Guidelines (eCCG), Data Management Plan (DMP), Data
- Validation Specification (DVS) etc.
- Help coordinate and track progress of eCRF build to ensure projects meet deadlines and achieve high data quality standards
- Create and review data validation check specifications. Coordinate relevant parties in the development and testing of eCRF and data validation checks
- Perform thorough user acceptance testing (UAT) on eCRF and data validation checks
- Ensure project data management documents are consistently filed within the project’s Trial Master File (TMF)
Background and Qualifications:
- B.A./B.S. in science/health-related field or equivalent plus 3+ years’ experience in Clinical Data Management in the Medical Device or Pharmaceutical/Biotechnology industry or equivalent combination of education and experience
- Advanced skills in various EDC systems, MediData Rave being preferred
- Experience in the entire life cycle of data management in clinical trials including EDC build, trial start-up, trial conduct and trial close out activities on global trials
- Experience creating DM standards and documentation
- Understanding of clinical trial methodology, clinical research and GCP regulations
Strong knowledge of industry best practices in clinical data management